Most patients in health care facilities are able to achieve sufficient caloric intake through eating prepared meals. However, a sizable number of such patients are unable to ingest enough food to meet their body's needs. Examples of these individuals would include burn patients, whose daily caloric needs are often in excess of 5,000 calories; critically ill, weak or comatose patients, who may be unable to chew their food; and patients suffering from cancer of the esophagus, who may be unable to swallow their food. For these patients, parenteral caloric supplementation, also known as intravenous feeding, is not a viable alternative.
In response to this problem, liquid foods have been developed for enteral feeding. Enteral feeding often utilizes a nasogastric tube to transport the liquid nutritional products from a container through the patient's nasal cavity and thence into the stomach. However, an increasing number of ambulatory patients utilize and prefer direct enteral feeding through gastrostomy devices.
While it is possible to place a primary gastrostomy device by means of a surgical procedure utilizing a general anesthetic, the preferred method for placement of these devices is through a percutaneous endoscopic gastrostomy (PEG) which involves the non-invasive, non-surgical creation of an artificial opening or stoma into the stomach through the abdominal wall using only local anesthetic. In a representative PEG procedure, an endoscope is passed down the throat until its terminus contacts the interior of the stomach wall. A needle, with stylet in place, is then inserted through the various tissue layers until it enters the stomach at a predetermined point. The stylet of the needle is retracted and a guidewire is then inserted through the cannula of the needle. The terminal end of the guidewire (now inside the stomach) is grasped using an endoscopic appliance and retracted up the throat. A primary gastrostomy tube is then inserted with the assistance of the guidewire so as to provide a direct enteral feeding conduit to the patient's gastric system.
To better understand the advantages associated with the instant invention, it is necessary to appreciate the distinctions between primary and secondary gastrostomy tubes. A primary gastrostomy tube, is the device used for the initial placement in the patient of a gastric enteral feeding tube. With a length of approximately 1 meter the primary tube has as its principle focus, the forming of a healthy stoma tract. In contrast, the approximately 225 mm secondary gastrostomy tube, assumes the presence of a healthy stoma tract and, in fact, is able to be physically pushed into position through an open stoma, following removal of the primary gastrostomy tube. Reasons why the primary gastrostomy tube may have to be removed include clogging due to the viscous character of enteral nutritional food product, the perforation of the mucosa wall, or just deterioration due to age. Primary gastrostomy tubes usually only last on average from three to twelve months. Additionally, the patient may accidentally or intentionally pull the primary tube out, thus requiring the insertion of a replacement tube. The prior art replacement gastrostomy devices comprise a catheter shaft enclosing a non-circular feeding lumen and a fluid flow channel with the fluid flow channel permitting the filling of an expandable component member so as to provide for the securing of the device with respect to the stomach wall.
In both primary and secondary gastrostomy tubes, a main feeding port permits the introduction of enteral nutritional product into the feeding lumen and thence into the stomach. The main feeding port is connected to a supply of nutritional product via an adapter set which accommodates various sizes of tubing. The devices according to the prior art provide only one access to the feeding lumen. As a result, these devices cannot be used for other than feeding purposes without disconnecting the pump set.
One aspect of the present invention resides in the "Y-port" connector which provides access to the feeding lumen for non-feeding purposes. Possible reasons for non-feeding access include gastric suction, decompression, the introduction of medication in the form of crushed pills or liquid, and maintenance associated with the gastrostomy tube. In gastric suction, the gastric contents of the stomach or small bowel are retrieved. Examples of such gastric contents could include mucous, air, bile, gastric juices or feeding residue. The retrieval of gastric residual content is extremely important for numerous reasons, including the determination of the proper rate of feeding. Health care professionals would find this feature extremely beneficial, since the prior art devices do not possess such a feature.
Individuals who utilize primary or secondary gastrostomy devices may encounter problems with a condition known as reflux. In reflux, the gastric residual is refluxed or vomited up the esophagus. In a weak or bedridden patient, or one who has no ability to swallow normally, reflux may result in the gastric residual being inhaled into the lungs and death from aspiration pneumonia can result. In order to provide gastric suction or introduce medication into the feeding lumen using prior art devices, it is necessary to disconnect the pump set or provide multiple hookups and thereby risk the problem of contamination.
For individuals who frequently encounter or are prone to problems with reflux, feeding can be accomplished by the use of a jejunal feeding tube which passes through the stomach, the pylorus and then enters the small bowel, the duodenum and the jejunum. However, a problem is encountered by patients attempting to use jejunal tubes with prior art replacement gastrostomy tubes in that the prior art failed to appreciate the problem of retraumatization.
Retraumatization, in addition to causing discomfort, also has the danger of infection and the potential for bleeding occurring due to the sensitive tissue present at the stoma. As a result of not appreciating the problem of retraumatization, replacement gastrostomy tubes have been designed with a circular outer cross-section and a non-circular cross-section for the feeding lumen and therefore Jejunal tubes can not be inserted therethrough.
Consequently, in cases where it becomes necessary for a patient with a secondary gastrostomy tube to be fed by the use of a jejunal feeding tube, the health care professional is typically confronted by three options, all of which will subject the patient to significant retraumatization. The first option is to remove the secondary gastrostomy tube and to replace it with another primary gastrostomy tube using a PEG procedure. The second option is to forcibly insert a larger outer diameter secondary gastrostomy tube through the stoma, in the hope that a sufficiently large inner diameter will be provided to permit the passage therethrough of a Jejunal tube. The third option is to surgically perform a jejunostomy, and insert the jejunal tube while the patient is under a general anesthetic. The only option available which will temporarily avoid retraumatization is to try to use a jejunal tube of a small French size with the existing replacement gastrostomy tube, however, this often results in clogging, especially in milk-based nutritional feeding products, so as to restrict or preclude feeding, thus ultimately necessitating removal of the replacement gastrostomy tube and the retraumatizing of the patient by one of the three aforementioned options.
Yet another problem encountered in gastrostomy tubes is that of kink resistance. When a tube kinks, its internal walls tend to collapse and fold upon the opposite side of the tube. This condition normally happens accidentally, as the patient turns in bed, but the result is that fluid flow is restricted or curtailed altogether. To increase kink resistance associated with a specific tube, the distance between the inner diameter of the catheter shaft and the outer diameter of the catheter shaft can be increased. However, too much of an increase in the thickness of the tube wall renders the tube inflexible, and reduces the feeding area associated with the feeding lumen for a device of a given outside diameter.
Examples of prior art gastrostomy feeding devices are shown in Parks U.S. Pat. Nos. 4,701,163 and 4,685,901. U.S. Pat. No. 4,701,163 device fails to appreciate the need for additional access to the feeding lumen. The configuration of the U.S. Pat. No. 4,701,163 feeding lumen (i.e. cross section) will not allow the passage of a J-tube.
U.S. Pat. No. 2,457,244 relates to a medical appliance for control of enemata. The medical appliance of U.S. Pat. No. 2,457,244 comprises an inflatable element upon the forward end of a pipe and a means operating to fit snuggly against the anus of the patient and in consequence hold the inflated balloon against the internal mouth of the anal canal. Of particular interest is FIG. 3 of the '244 patent which illustrates a common non-circular cross section of tubes utilizing an inflatable member.
Austrian patent 364,721 relates to a catheter for establishing a fluid line between the exterior of the body and the bladder or the renal pelvis in the form of a hose which is surrounded by a dilatable means which can be expanded after introduction into the interior of the body, said hose having an extension which protrudes from the dilatable means. This patent fails to consider the specific needs for replacement or secondary feeding tubes. Specifically, this reference fails to suggest a Y-port for the feeding lumen and the need for J-tube insertion after the tube is in place.
U.S. Pat. No. 3,915,171 relates to a gastrostomy tube for insertion into the stomach and for retention as a consequence of bearing engagement against the inside stomach wall and the outside abdominal wall. The patent also discloses a conduit which carries a stiffly flexible retention bulb which can be collapsed by a stylet for insertion through a stab wound through the stomach. In the stomach the bulb resumes it normal shape when the stylet is withdrawn. The device disclosed in this reference would not permit the passage of a J-tube.
U S. Pat. No. 4,516,968 discloses a catheter shield and method of use. U.S. Pat. No. 4,393,873 relates to gastrostomy and other percutaneous transport tubes which contain anti-reflex valves. Both of these references fail to disclose the device of the instant invention which allows for the passage of a J-tube and access to the feeding lumen without disconnecting the feed set.
An article by Gerald Moss in the Journal of Parentenal and Enteral Nutrition, Vol. 8, No. 2 entitled "Efficient Gastroduodenal Decompression with Simultaneous Full Enteral Nutrition: A New Gastrostomy Catheter Techniques" discloses a gastrostomy tube designed to provide efficient supplemental aspiration of the proximal duodenum to remove gas that escapes gastric removal, utilizing an extension of the gastric suction channel.
It is thus apparent that the need exists for an improved replacement gastrostomy tube. The prior art fails to suggest or disclose an improved replacement tube which provides additional means of access to the feeding lumen, permits the use of jejunal tubes, and maximizes the feeding area of the tube, while at the same time overcoming additional drawbacks associated with existing replacement gastrostomy tubes.